FDA approval is required for Class III medical devices (like heart valves) and treatments for diseases. It is not required for things like fitness trackers and dietary supplements. Clinical trials are run for treatments like the recent Covid vaccines, and on average take 12 years to complete.
Nice summary! After 9 years in the pharma commercialization industry, I'd like to add that sometimes Phase II/III occur together for rare diseases since it takes so long and is so hard to enroll all patients. Data releases from P2 and P3 are huge days for pharma companies.
Nice summary! After 9 years in the pharma commercialization industry, I'd like to add that sometimes Phase II/III occur together for rare diseases since it takes so long and is so hard to enroll all patients. Data releases from P2 and P3 are huge days for pharma companies.